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As medical content evolves from focusing on technical and scientific information to also incorporating patient- and consumer-targeted communication, and as the range of regulatory documents expands, medical writing remains a highly valued and in-demand...
1 min read
At Veristat, we recently embarked on an ambitious journey alongside a biotech organization specializing in gene therapies for metabolic diseases. Our engagement entailed supporting their Phase I/II clinical study for a rare human genetic lysosomal...
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Precision and efficiency are key in the intricate world of CNS drug development. Veristat's recent collaboration with a clinical-stage biopharmaceutical company showcases an agile medical writing and project management approach, revolutionizing the...
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RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site...
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Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm...
3 min read
Veristat has experience in preparing more than 120 marketing applications. Our exposure to in creating new drug applications (NDAs) and marketing authorization applications (MAAs) has taught us two main lessons:
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When database locks are delayed, or regulatory agencies request additional analyses for new drug applications (NDAs) or marketing authorization applications (MAAs), it seems there is no alternative but to take a hit to the timeline — or is there?
2 min read
When a team faces multiple submissions in a short timeframe or even simultaneous submissions, uncertainty over timeline organization and the best way to utilize medical writers can be paralyzing.